Overview
Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
Status:
Completed
Completed
Trial end date:
2016-03-21
2016-03-21
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of the study is to determine whether topical ocular administration of LME636 60 mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC) associated with acute anterior uveitis (AAU).Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Alcon ResearchTreatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Ophthalmic Solutions
Pharmaceutical Solutions
Criteria
Inclusion Criteria:- Provide written informed consent.
- Diagnosis of non-infectious AAU in at least 1 eye.
- Anterior chamber cell score of 2+ or 3+ as per Standardization of Uveitis Nomenclature
(SUN) in at least one eye.
- Able to communicate well with the Investigator, to understand and comply with the
requirements of the study.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Women of child-bearing potential unwilling to use effective contraception methods as
defined in the protocol.
- AC cell score of 4+ (SUN) or hypopyon.
- Onset of anterior uveitis more than 2 weeks prior to enrollment in the study.
- Presence of intermediate-, posterior-, or panuveitis in either eye.
- Administration of stable doses >10 mg daily systemic prednisone or corticosteroids as
described in the protocol.
- Recurrent corneal abrasion or ulceration in either eye (past or present).
- Tuberculosis (past or present).
- Other protocol-specified exclusion criteria may apply.